Repetitive Transcranial Magnetic Stimulation Effects on Clinical, Cognitive and Social Performance in Postpartum Depression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale (HDRS)
研究概览
简要总结
Several factors characterize repetitive transcranial magnetic stimulation (rTMS) as a strategic aid in the treatment of postpartum depression.
However, up to current days there have been no studies evaluating the effects of rTMS on neurocognitive and social performance of women suffering from the disorder.
The present study evaluates the impacts of rTMS in clinical, cognitive and social performance.
详细描述
Transcranial magnetic stimulation is a noninvasive technique that can influence specific areas of the brain and has very few side effects.
The treatment with transcranial magnetic stimulation requires attendance to hospital daily sessions for 4 consecutive weeks. Each session lasts up to 30 minutes.
Side effects include scalp discomfort and mild headache. No anesthesia is required.
Stimulation aims the dorsolateral prefrontal cortex, a region previously studied to treat depression symptoms with positive results.
The present technique has never been employed in previous studies, but risks are insignificant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 36 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •major depression with a puerperal onset, according to the criteria of the DSM-IV-R (APA, 2000), as well as through a structured clinical interview (SCID-1/P v 2.0)
- •baseline score of at least 14 points on the Hamilton Depression rating Scale-17 items
- •baseline score of at least 13 points on the Edinburgh Postnatal Depression Scale.
- •range = 18-36 years
- •women who had given birth 1-6 months
- •any pharmacological treatment other than clonazepam (1 mg/day)
排除标准
- •comprised ferromagnetic metallic implants
- •pacemakers
- •previous neurosurgery
- •history of seizures
- •major head trauma
- •alcoholism
- •drug addiction
- •any psychiatric or neurological disorder other than depression and anxiety
- •psychotic depression
- •suicidal propensities
结局指标
主要结局
Hamilton Depression Rating Scale (HDRS)
时间窗: 6 weeks
Reduction on the scores of HDRS (as on the scores of Edinburgh Pospartum Depression Scale and Hamilton Anxiety Scale; and improves the global clinical status in Clinical Global Impression, Global Assessment Scale and 36-item Short-form Health Survey - Quality of Life)
次要结局
- Battery of Neuropsychological Tests and Social Adjustment Scale(6 weeks)
研究者
Eduardo Moacyr Krieger
Associate Professor
University of Sao Paulo General Hospital